A Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated Malaria

The study duration is 30 days including a 2 day screening period, a 3 day treatment period with a follow-up period of 25 days. Patients remain hospitalized 4 days.

Inclusion criteria

• Body weight between 50 kg and 90 kg with Body Mass Index >18 kg/m²
• Presence of body temperature ≥ 37.5°C or history of fever within the last 24 hours
• Monoinfection with Plasmodium falciparum and parasitemia within the 100 to 200,000/microL

Exclusion criteria

• Hypersensitivity to quinoleines or artesunate
• History or presence of any clinically significant disease or symptoms which, in the judgment of the investigator, might confuse the interpretation of the safety and efficacy information
• Splenectomized patients
• Laboratory parameters outside normal ranges
• Presence of HBs antigen, anti-HCV antibodies and anti-HIV 1&2 antibodies
• Cardio vascular and Electrocardiogram parameters outside normal values
• Presence of criteria of complicated malaria
• Permanent vomiting
• Previous treatment within 5 times the elimination half-life of any anti-malaria agents or with any marketed or investigational drugs (including St John's Wort) within 14 days before administration, or within 5 times the elimination half-life of that drug, whichever the longest, especially CYP3A and 2D6 main substrates
• Positive results on urine drug screen for anti-malaria agents (aminoquinolines)
• History of drug or alcohol abuse (alcohol consumption > 40 grams/day ; i. e. 2.5 beers of 33cl with 5 degrees of alcohol)
• Intention to use herbal medicine during the study period
• Immunization injection within last 15 days

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.